PRA Health Sciences - Drug Development Solutions White Papers

Bioanalysis of Biosimilars
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.
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ECG Assessments During the Development of Oncology Compounds
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
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Biosimilars in Emerging Markets Is It A Level Playing Field?
Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need.
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On-Site Manufacturing in Early Clinical Drug Development (in Europe)
Written by Suzanne Jansen MSC, Pharmacist and Arjen Akkerman, MSc Senior Manager.
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The Value of Biobetters
The market of biologics is growing at a nearly twice the rate of pharma as a whole. Biologics are expected to account for approximately 17% of total global spending on medicines by 2016, and reach an overall market value of $200 billion to $210 billion in 2016, up from $157 billion in 2011.Seven of the top 10 global medicines by spending will be a biologic within the next 5 years.
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Global Biosimilar Development
Many different terms are used in different parts of the world to describe “biosimilar products.” It is important to understand and differentiate true biosimilars from others because of the potential concern for patient safety and efficacy, and the misconceptions that can arise from misleading published reports.
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Global Capabilities in Central Nervous System Research
PRA Health Sciences’ (PRA) Early Development Services (EDS) group has a long-standing track record of early clinical development work in various CNS indications through our global clinical facilities.
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Sponsor and CRO Pharmacovigilance Alliances
Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today.
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Translating Cancer Genomics Into a Personalised Approach for Cancer Patients
This white paper provides a brief history of oncology genomics, including development,
uses in improving patient care, current achievements and challenges and the future
direction of cancer genomics.
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Favourable Regulatory Procedures in The Netherlands Phase I-IIa
The EU Clinical Trials Directive (CTD) has been fully implemented in The Netherlands. Prior to beginning to a clinical trial, an identical Clinical Trial Application (CTA) dossier must be submitted to an accredited Ethics Committee (EC) and to the Central Commision on Research in Humans (the Competent Authority [CA] in The Nettherlands).
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Risk - Based Monitoring for Late - Phase Research: Strategies for Real - World, Post - Approval Studies
The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV).
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Risk Management Planning and Mandated Post - Authorisation Studies: Risk Management and Late Phase Studies for Real-World Research
Complex pharmacovigilance legislation in an evolving regulatory landscape has left drug makers searching for current, efficient and more meaningful solutions for their drug safety challenges, especially in the post-marketing arena. Companies are seeking expert advice and customised approaches to effectively collect, manage and analyse real-world evidence for a competitive advantage.
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Human ADME and Studies with Radiolabeled Compounds: Phase I-IIa
Radiolabeled medication is widely used in the assessment of human ADME and also increasingly in assessing absolute bioavailability (BA). Conducting an ADME study early in the clinical development program - generally before or in parallel with Phase IIa - is prudent since the outcome may generate the need for additional toxicology studies.
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Hepatic Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support
PRA Early Development Services (EDS) has established a group of experts dedicated to early phase patient studies. Our innovative Patient Pharmacology Services (PPS) features a unique scientific/medical and operational model that enables us to conduct studies in patients with hepatic impairment following the same processes and guidelines that we apply to traditional Phase I or Phase IIa trials.
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Renal Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support
It is recommended to have renal impairment trials conducted relatively early in
the clinical development process, because the outcome may influence the patient
population as well as the inclusion and exclusion criteria of Phase II and III trials.
The timing of these trials is generally before or in parallel with Phase II.
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Seamless Drug Development
The success rate of drug development has been studied extensively over the years
and discussed in numerous publications. In an important recent paper by Hay
et al (Nat Biotechnol. 2014;32:40-51), the overall likelihood of FDA approval for
products entering clinical phase was estimated at approximately 10%.
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